Participate to the qualification-validation strategy for the processes and activities for which you are responsible (internally and externally)
Work in close collaboration with R&D, Operations and RA departments and with sub-contractors to qualify their processes
Managing and monitoring Additive Manufacturing qualification activities, including environmental monitoring and requalification
Coordinating/executing validation activities (IQ/OQ/PQ) for equipment, utilities, and cleanroom systems
Leading investigations, root cause analysis, CAPA, and non-conformity resolution linked with clean room environment
Ensuring compliance with ISO 13485, ISO 14971, 21 CFR Part 820, EU MDR 2017/745, and internal quality systems
Analysing quality metrics and identifying opportunities for continuous improvement
Creating, Reviewing and approving quality documentation, SOPs, protocols, and reports
Interacting with auditors
Collaborating with Production, Engineering, Regulatory Affairs, and suppliers
Participating to DHF completeness
Defining, Planning, executing and reviewing all validation/verification activities
Managing all changes including impact assessment

Proven experience in Validation and Qualification processes, with demonstrated use of ISO 13485, ISO 14971, 21 CFR Part 820, and EU MDR 2017/745
Minimum of 3 years’ experience in additive manufacturing using metallic materials
Experience in orthopaedics and/or spinal medical device development is a strong advantage
Higher education degree in Engineering, preferably Mechanical Engineering
Ability to work effectively in English; native or near-native level of French
Excellent technical writing skills, including structured documentation such as protocols, reports, and audit-ready records
Ability to manage multiple projects and validation activities under tight deadlines
Ability to challenge decisions that may impact patient safety or regulatory compliance
Strong problem-solving skills with a pragmatic and solution-oriented approach
Valid driving licence

Spineart

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